New U.S. Veterinary Biological Establishment Licenses and Permits (new permittees) were issued as

follows:

________________________________________________________________

New U.S. Veterinary Biologics Product Licenses and Biological Product Permits (new codes) were

issued as follows:

United States Department of Agriculture

Animal and Plant

Health Inspection

Services

Veterinary Services

Center for Veterinary

Biologics

1920 Dayton Ave

PO Box 844

Ames, IA 50010

(515) 337-6100

CENTER FOR VETERINARY BIOLOGICS NOTICE NO. 16-16

TO: Biologics Licensees, Permittees, and Applicants

Directors, Center for Veterinary Biologics

Veterinary Services Leadership Team

FROM: Byron Rippke

Director

SUBJECT: Issuance of Licenses

The purpose of this notice is to bring to the attention of interested parties licenses issued and

terminated between July 01, 2016 and September 30, 2016. These do not include those licenses

reissued to update pertinent information.

Est. Name and Address Est. No. Type

Thermo Fisher Scientific

Austin, TX

582C Permittee

True Name Code Est. Name/No.

Autogenous Bacterin 2051.01 Biomune Company/Est No. 368

Autogenous Bacterin B051.02 Hennessy Research Associates,

LLC/Est No. 597

Autogenous Bacterin B051.03 Hennessy Research Associates,

LLC/Est No. 597

Autogenous Bacterin B051.04 Hennessy Research Associates,

LLC/Est No. 597

Autogenous Vaccine, Killed Virus 1015.20 Antelope Valley Bios, Inc./Est No. 419

Autogenous Vaccine, Killed Virus A015.21 Hennessy Research Associates,

LLC/Est No. 597

Autogenous Vaccine, Killed Virus, Autogenous Bacterin 4500.20 Biomune Company/Est No. 368

Autogenous Vaccine, Killed Virus, Autogenous Bacterin D500.21 Hennessy Research Associates,

LLC/Est No. 597

Autogenous Vaccine, Killed Virus, Autogenous Bacterin D500.22 Hennessy Research Associates,

LLC/Est No. 597

Avian Influenza-Marek's Disease Vaccine, H5 Subtype, Serotype 3, Live Marek's

Disease Vector

1062.R2 Biomune Company/Est No. 368

Bordetella Bronchiseptica Vaccine, Avirulent Live Culture 1081.02 Intervet Inc./Est No. 165A

Borrelia Burgdorferi Bacterin 2126.01 Boehringer Ingelheim Vetmedica,

Inc./Est No. 124

Canine Distemper-Adenovirus Type 2-Parvovirus Vaccine, Modified Live Virus,

Live Canarypox Vector, Leptospira Canicola-GrippotyphosaIcterohaemorrhagiae-Pomona Bacterin

47M9.R0 Merial, Inc./Est No. 298

Foot and Mouth Disease Virus Antibody Test Kit 5FM0.20 Thermo Fisher Scientific/Est No. 582C

Newcastle Disease Vaccine, VG/GA Strain, Live Virus 17A2.V2 Merial, Inc./Est No. 298

Parvovirus-Swine Influenza Vaccine, H1N1 & H1N2 & H3N2, Killed Virus,

Erysipelothrix Rhusiopathiae-Leptospira Bratislava-Canicola-GrippotyphosaHardjo-Icterohaemorrhagiae-Pomona Bacterin

49F6.2B Zoetis Inc./Est No. 190

An Equal Opportunity Provider and Employer
CENTER FOR VETERINARY BIOLOGICS NOTICE NO. 16-16

Page 2

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U.S. Veterinary Biologics Establishment Licenses and Permits (Permittees) were terminated without

prejudice as follows:

________________________________________________________________

U.S. Veterinary Biological Product Licenses and Permits (codes) were terminated without prejudice

as follows:

________________________________________________________________

There were no Product Licenses or Permits (codes) issued due to an acquisition this quarter.

True Name Code Est. Name/No.

Parvovirus-Swine Influenza Vaccine, H1N1 & H1N2 & H3N2, Killed Virus,

Erysipelothrix Rhusiopathiae-Leptospira Canicola-Grippotyphosa-HardjoIcterohaemorrhagiae-Pomona Bacterin

49G6.2B Zoetis Inc./Est No. 190

Swine Influenza Vaccine, H1N1 & H1N2 & H3N2, Killed Virus, Erysipelothrix

Rhusiopathiae-Mycoplasma Hyopneumoniae Bacterin

4994.2D Zoetis Inc./Est No. 190

Swine Influenza Vaccine, H1N1 & H1N2 & H3N2, Killed Virus, Mycoplasma

Hyopneumoniae Bacterin

4995.2D Zoetis Inc./Est No. 190

Swine Influenza Vaccine, H1N1 & H1N2 & H3N2, Killed Virus 19A5.2C Zoetis Inc./Est No. 190

Swine Influenza Vaccine, H1N1 & H1N2 & H3N2, Killed Virus 19A5.2B Zoetis Inc./Est No. 190

Swine Influenza Vaccine, H1N1 & H1N2 & H3N2, Killed Virus, Erysipelothrix

Rhusiopathiae Bacterin

4993.2B Zoetis Inc./Est No. 190

Swine Influenza Vaccine, H1N1 & H1N2 & H3N2, Killed Virus, Mycoplasma

Hyopneumoniae Bacterin

4995.2C Zoetis Inc./Est No. 190

Est. Name and Address Est. No. Type

International Immunology Corp. 361 Licensee

True Name Code Est. Name/No.

Allergenic Extract, Prescription Product 9531.01 ALK-Abello, Inc./Est No. 259

Anaplasma Antibody Test Kit 5002.00 Veterinary Diagnostic Technology,

Inc./Est No. 336

Avian Encephalomyelitis Virus, Live Virus A051.10 Elanco US Inc./Est No. 196

Bluetongue Virus Antibody Test Kit, Complement Fixation Test 5010.10 Veterinary Diagnostic Technology,

Inc./Est No. 336

Bovine Rhinotracheitis-Virus Diarrhea Vaccine, Modified Live Virus, Leptospira

Pomona Bacterin

4389.20 Merial, Inc./Est No. 298

Canine Heartworm Antiserum, Rabbit Origin E019.00 International Immunology Corp./Est

No. 361

Classical Swine Fever Virus RNA Test Kit, Polymerase Chain Reaction 5441.80 Tetracore, Inc./Est No. 644

Escherichia Coli Antibody, Bovine Origin C526.00 International Immunology Corp./Est

No. 361

Feline Leukemia Virus Antiserum, Rabbit Origin E026.00 International Immunology Corp./Est

No. 361

Neorickettsia Risticii Bacterin 2639.00 ProtaTek International, Inc./Est No. 329

Neorickettsia Risticii Bacterin, Killed Culture B639.00 ProtaTek International, Inc./Est No. 329

Neorickettsia Risticii, Killed Culture B639.01 ProtaTek International, Inc./Est No. 329

Newcastle-Bronchitis Vaccine, Mass & Ark Types, Killed Virus 1785.10 Elanco US Inc./Est No. 196

Pasteurella Multocida Bacterin, Avian Isolates, Types 1 & 3 & 4 B702.15 Elanco US Inc./Est No. 196

Trueperella Pyogenes-Escherichia Coli-Mannheimia Haemolytica-Pasteurella

Multocida-Salmonella Typhimurium Antibody, Bovine Origin

C391.00 Colorado Serum Company/Est No. 188

An Equal Opportunity Provider and Employer